A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill
Case Western Reserve University
Summary
Every year in the United States, millions of adults make crucial medical decisions for loved ones in the intensive care unit while facing extreme emotional stress. This project will assess REFRAME, a brief tablet-based program designed to help decision-makers manage their emotions in these situations. Results from this study may lead to the creation of a widely accessible tool that alleviates emotional suffering and enhances the quality of medical decision-making for families in crisis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Patient Inclusion Criteria: * 1\. Age ≥ 35 years * 2\. Lacks decision-making capacity * 3\. Not expected to be discharged from the ICU in 24 hours (including death) Legally Authorized Representative Inclusion Criteria (Primary Participant) * 1\. Age ≥ 18 years * 2\. Identified as LAR by ICU team * 3\. Able to speak and understand English * 4\. Able to visualize content on a tablet device Patient Exclusion Criteria: * 1\. Age \< 35 years * 2\. Possesses decision-making capacity * 3\. Anticipated discharge from ICU within next 24 hours. Legally Authorized Representative Exclusion Criteria:…
Interventions
- BehavioralREFRAME
consists of three self-guided, tablet-based modules that align with the process model of emotion regulation. Each module lasts approximately 10-20 minutes and is delivered sequentially over three sessions, spaced 24-48 hours apart after enrollment.
- BehavioralInformational Support
The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.
Location
- University Hospitals Cleveland Medical CenterCleveland, Ohio